DIRECT CROWN NATURAL 1

K101814 · Candulor USA, Inc. · EBG · Sep 27, 2010 · Dental

Device Facts

• Record ID: K101814
• Device Name: DIRECT CROWN NATURAL 1
• Applicant: Candulor USA, Inc.
• Product Code: EBG · Dental
• Decision Date: Sep 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.

Device Story

Direct Crown Natural 1 is a dental resin material used for fabricating temporary crowns and bridges. It functions by utilizing pre-formed Direct Crown shell teeth as a base or form, which are then filled or adapted with the resin to create the temporary restoration. The device is intended for use by dental professionals in a clinical setting. It provides a temporary solution for patients needing crown or bridge work, allowing for functional and aesthetic restoration while awaiting permanent dental prosthetics. The resin is applied chairside to the shell teeth, which are then placed in the patient's mouth to set, facilitating the creation of custom-fit temporary restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary crown and bridge resin material. Formulated for use with pre-formed shell teeth. Class II medical device under 21 CFR 872.3770.

Indications for Use

Indicated for patients requiring short or long-term temporary crowns and bridges, with a duration of use up to 12 months.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Donna Marie Hartnett Regulatory Correspondent Candulor USA, Incorporated 7462 North Figueroa Street, Suite 104 Los Angeles, CA 90041

### SEP 2 7 2010

Re: K101814

Trade/Device Name: Direct Crown Natural 1 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 3, 2010 Received: June 29, 2010

Dear Ms. Hartnett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register ...

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#### Page 2 – Ms. Hartnett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" " (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

9/27/2010

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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## Indications for Use

SEP 27 2010

# 10/8/4

510(k) Number (if known):

Device Name: Direct Crown Natural 1

Indications For Use:

Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Susan Gunner

(Division Sign-Off) Division of Anesthesiology, General Hospitai Infection Control, Dental Devices

510K application Direct Crown Natural 1 Page 7

510(k) Number: